Human Factors Validation Testing is now an FDA requirement for regulatory clearance of most medical and drug-delivery devices. We help device manufacturers and pharmaceuticals through the process, designing and conducting successful validations studies for submission to the FDA.

Device manufacturers are required by many regulatory bodies to utilize human factors engineering during product development. We help companies understand their obligations, plan for them, and conduct human factors activities to help meet their regulatory requirements.

User research provides practical insights into product usage and requirements. We use an ethnographic combination of point-of-use observation and interview techniques to understand how people are using your product today and what they need going forward.

Good user interface design isn’t flashy. It need not push the envelope of engineering complexity. A highly usable design is simple, transparent, and in hindsight, obvious. We offer several approaches to addressing your user interface design and evaluation needs.